FDA Slams Hims & Hers With A Warning Letter. Investors Slam Hims Stock.

Core Viewpoint - Hims & Hers Health (HIMS) faces significant stock decline following an FDA warning regarding its compounded semaglutide product, which is marketed as a cheaper alternative to Novo Nordisk's branded drugs [1][2]. Company Overview - Hims & Hers Health is a telehealth company that offers a range of products including skin care, sexual health, and hair-loss treatments, gaining prominence with its compounded semaglutide launched in May 2024 [3][4]. - The company has been leveraging a loophole to sell personalized doses of semaglutide after the FDA declared a shortage of the branded version was over [4]. Regulatory Issues - The FDA's warning letter, dated September 9, states that Hims' claims about its compounded product being equivalent to FDA-approved drugs are misleading, as compounded drugs are not FDA-approved [2][5]. - Hims has 15 days to respond to the FDA's letter, either by addressing the alleged violations or providing evidence that its products comply with regulations [5]. Stock Performance - Hims stock experienced volatility, reaching a high of nearly 73 in February, dropping to around 24 in April, and then climbing back above 70 in July before falling to approximately 41 recently [6]. - Following the FDA warning, Hims stock dropped over 7% to 49.91, hitting its 50-day moving average [2][6].